54
13.
Performance characteristics
Precision
Standard deviation (SD) for each glucose
concentration < 5.55 mmol/L and coefficient of
variation (CV) for each glucose concentration
≥
5.55 mmol/L) is
≤
0.278 mmol/L and
≤
5.0%,
respectively.
Intermediate precision
Control Solution Level
(mmol/L)
Low
(1.7~2.8)
Normal
(5.3~8.0)
High
(15.6~23.3)
Pooled
Mean (mmol/L) 2.5
5.6
19.6
SD
3.0
3.0
8.1
CV (%)
-
3.0%
2.3%
Repeatability
Blood Glucose
(mmol/L)
1.7~
2.8
2.9~
6.1
6.2~
8.3
8.4~
13.9
14.0~
22.2
Pooled Mean
(mmol/L)
2.2
4.6
7.2
11.2
18.0
SD
2.6
3.7
5.1
6.6
8.4
CV (%)
6.5%
4.5%
3.9%
3.3%
2.6%
System Accuracy
System accuracy results for glucose
concentration <5.6 mmol/L
Within ±0.28
mmol/L
Within ±0.56
mmol/L
Within ±0.83
mmol/L
114/180 (63.3%)
172/180 (95.6%)
180/180 (100%)
System accuracy results for glucose
concentration
≥
5.6 mmol/L
Within ±5%
Within ±10%
Within ±15%
215/420 (51.2%)
336/420 (80.0%)
408/420 (97.1%)
13.
Performance characteristics
